Prospective cohort study to evaluate safety and immunogenicity of the fragmented, inactivated trivalent Influenza vaccine produced at Butantan Institute in healthy adults and elderly. The study will include a total of 120 participants: 60 participants aged 18 to 59 years in the healthy adults group, and 60 participants aged older than 60 years in the elderly group.This study will evaluate the safety of one dose of the fragmented, inactivated trivalent Influenza vaccine in the first 3 days after vaccination, as well as its immunogenicity 21 days after vaccination.
Study Type
OBSERVATIONAL
Enrollment
120
Subjects participating in the study are exposed to Butantan´s Fragmented Inactivated Trivalent Influenza Vaccine during vaccination campaign, and will have immunogenicity and safety related to the vaccine evaluated (observational study).
Vaccine Immunogenicity
Antibody response to each of the vaccine´s strains as measured by % seroconversion, increase in the geometric mean of hemagglutination-inhibition (HAI) titers and % seroprotection.
Time frame: 21 days
Vaccine safety assessed by unsolicited local and systemic adverse reactions up to 3 days post vaccination
Time frame: 3 days
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